美国FDA药品数据库（U.S. FDA Drugs Database）
检索条件:" 药品名称=DOLUTEGRAVIR"
符合检索条件的记录共 26 条
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商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
DOLUTEGRAVIR SODIUM 208355 001 ANDA DOLUTEGRAVIR SODIUM TABLET;ORAL 50MG No No 2016/09/19 (TA) -- AUROBINDO PHARMA LTD None (Tentative Approval)
DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE 209670 001 NDA DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 50MG;300MG;300MG No No 2017/08/02 (TA) -- MYLAN PHARMS INC None (Tentative Approval)
DOLUTEGRAVIR SODIUM 209658 001 ANDA DOLUTEGRAVIR SODIUM TABLET;ORAL 50MG No No 2018/03/05 (TA) -- CIPLA LTD None (Tentative Approval)
DOLUTEGRAVIR SODIUM 209602 001 ANDA DOLUTEGRAVIR SODIUM TABLET;ORAL 50MG No No 2018/07/06 (TA) -- MYLAN LABS LTD None (Tentative Approval)
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 210787 001 NDA DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 50MG; 300MG;300MG No No 2019/02/01 (TA) -- LAURUS LABS LTD None (Tentative Approval)
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 210796 001 NDA DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 50MG/300MG/300MG No No 2019/03/25 (TA) -- MACLEODS PHARMS LTD None (Tentative Approval)
DOLUTEGRAVIR SODIUM 210963 001 ANDA DOLUTEGRAVIR SODIUM TABLET; ORAL 50MG No No 2019/05/16 (TA) -- LAURUS LABS LTD None (Tentative Approval)
DOLUTEGRAVIR SODIUM 212179 001 ANDA DOLUTEGRAVIR SODIUM TABLET;ORAL 50MG No No 2019/09/13 (TA) -- MICRO LABS LTD None (Tentative Approval)
DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE 213556 001 NDA DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 50MG; 300MG; 300MG No No 2020/10/06 (TA) -- SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD None (Tentative Approval)
DOLUTEGRAVIR SODIUM 214566 001 NDA DOLUTEGRAVIR SODIUM TABLET; ORAL SUSPENSION 10MG No No 2021/03/16 (TA) -- MACLEODS PHARMS LTD None (Tentative Approval)
DOLUTEGRAVIR SODIUM 214397 001 ANDA DOLUTEGRAVIR SODIUM TABLET;ORAL EQ 10MG BASE No No 2021/03/22 (TA) -- MACLEODS PHARMS LTD None (Tentative Approval)
DOLUTEGRAVIR SODIUM 214397 002 ANDA DOLUTEGRAVIR SODIUM TABLET;ORAL EQ 25MG BASE No No 2021/03/22 (TA) -- MACLEODS PHARMS LTD None (Tentative Approval)
DOLUTEGRAVIR SODIUM 214397 003 ANDA DOLUTEGRAVIR SODIUM TABLET;ORAL EQ 50MG BASE No No 2021/03/22 (TA) -- MACLEODS PHARMS LTD None (Tentative Approval)
DOLUTEGRAVIR SODIUM 210812 001 ANDA DOLUTEGRAVIR SODIUM TABLET;ORAL 50MG No No 2021/05/18 (TA) -- CIPLA LTD None (Tentative Approval)
DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE 212303 001 NDA DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE TABLET; ORAL 50MG/300MG/300MG No No 2021/06/25 (TA) -- LUPIN PHARMS None (Tentative Approval)
DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE 212527 001 NDA DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE TABLET, FOR SUSPENSION; ORAL EQ 50MG BASE; 300MG; 25MG No No 2022/03/30 (TA) -- CIPLA USA INC. None (Tentative Approval)
ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE 216223 001 ANDA ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE TABLET;ORAL 600MG;50MG;300MG No No 2022/08/11 (TA) -- LAURUS LABS LTD None (Tentative Approval)
DOLUTEGRAVIR; RILPIVIRINE 213120 001 ANDA DOLUTEGRAVIR;RILPIVIRINE TABLET;ORAL 50MG/25MG No No 2023/01/13 (TA) -- LUPIN LTD None (Tentative Approval)
DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE 214544 001 NDA DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE TABLET;ORAL 50MG;200MG;25MG No No 2023/01/19 (TA) -- LUPIN LTD None (Tentative Approval)
DOLUTEGRAVIR 215319 001 NDA DOLUTEGRAVIR FILM;ORAL 5MG No No 2023/04/28 (TA) -- LAURUS GENERICS INC Prescription
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